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CompletedNCT05028816Updated Jul 2, 2025Results posted

Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction

An interventional study of Side 1: Final layer closure with force modulating tissue bridges (FMTB) and Side 1: Final layer dermal closure with poliglecaprone 25 suture in Surgical Incision, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern

Read the detailed description

This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device.

02

Conditions studied

  • Surgical Incision

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Keywords

  • Wound Healing
03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 39 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult females 18-65 years of age
  2. Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
  3. Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
  4. Willing to follow wound care therapy as instructed by study staff.
  5. Willing to return for follow up visits and undergo study evaluations.

Exclusion criteria

Exclusion Criteria:

  1. Individuals diagnosed with known allergy to general adhesives/adhesive tape

  2. Individuals with a history of using the following prescription medications:

    • Accutane within the past year;
    • Systemic steroid use within the past year
  3. Individuals who have significant scarring on the test site/area(s)
  4. Individuals with malnutrition
  5. Individuals who have a body mass index >35
  6. Individual who have a history of radiation therapy
  7. Individual who have a history of breast cancer
  8. Active smokers
  9. Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease
  10. Individual who have an observable pre-operative or intra-operative breast asymmetry that, in the investigators opinion, would interfere with the evaluation of the efficacy of the wound therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • Other
    Group 1

    Side 1: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA)

    Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture · Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)

  • Other
    Group 2

    Side 1: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) Side 2: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ)

    Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB) · Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture

Interventions

  • DeviceSide 1: Final layer closure with force modulating tissue bridges (FMTB)

    Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

    Also known as: Brijjit

  • OtherSide 1: Final layer dermal closure with poliglecaprone 25 suture

    Current method of wound closure

  • DeviceSide 2: Final layer closure with force modulating tissue bridges (FMTB)

    Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

    Also known as: Brijjit

  • OtherSide 2: Final layer dermal closure with poliglecaprone 25 suture

    Current method of wound closure

06

What researchers measure

Primary outcomes

  1. Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 12 Months

  2. Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 6 Months

  3. Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 3 Months

  4. Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 3 Months

  5. Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 12 Months

  6. Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M

    Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

    Time frame: 6 Months

Secondary outcomes

  1. Scar Area Assessment

    eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints.

    Time frame: Week 2, Week 4, Week 6 and Week 8

  2. Gene Regulation- Elastin

    Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  3. Gene Analysis- Macrophage

    Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  4. Histology Collagen 3

    Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  5. Change in Mechanical Properties of Human Tissue

    BTC2000 is used to assess changes in skin laxity and elasticity in skin that was treated with each closure. Skin maximum pressure, laxity, elastic/viscoelastic/ultimate deformation, and elasticity is measured to track changes through multiple timepoints.

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

  6. Histology Collagen 1

    Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  7. Scar Maximum Depth

    eKare will be used to asses scar area

    Time frame: Week 2, Week 4, Week 6 and Week 8

  8. Interleukin-8 (IL8)

    IL8 is a small protein called a chemokine that play a crucial role in the body's immune and inflammatory responses. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  9. Interleukin-6 (IL6)

    IL6 is an inflammatory cytokineses that measures acute phase response following treatment. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

  10. Measure of the Skins Function

    TEWL is a skin measurement to objectively measure the skins barrier function. The device measures the rate at which water evaporates from the skins surface

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

  11. Change in Tissue Density

    Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

  12. Change in Tissue Thickness

    Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

  13. Change in Tissue Stiffness

    Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

  14. Change in Tissue Energy Absorption

    Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

07

Results

Posted Jul 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneFMTB Left/ SOC RightSOC Left/FMTB Right
Started2016
Completed1012
Not completed104
Withdrew: Lost to follow-up53
Withdrew: Withdrawal by subject41
Withdrew: Physician decision10

Outcome measures

PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
12 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M
score on a scaleFTMB ScarSOC Scar
Pain1.09 ± 0.421.22 ± 0.74
Itchiness1.3 ± 1.061.87 ± 1.96
Color4.22 ± 2.921.22 ± 0.74
Stiffness2.17 ± 1.612.39 ± 1.99
Thickness2.74 ± 2.032.74 ± 2.22
Irregularities2.70 ± 1.612.70 ± 1.87
Total Score14.22 ± 7.2515.22 ± 8.63
Overall Opinion3.17 ± 1.873.04 ± 2.14
PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
6 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
score on a scaleFTMB ScarSOC Scar
Pain1.05 ± 0.231.00 ± 0
Itchiness1.11 ± 0.321.22 ± 0.55
Color4.37 ± 2.674.53 ± 2.99
Stiffness3.32 ± 2.433.32 ± 2.24
Thickness3.95 ± 2.663.58 ± 2.73
Irregularity4.16 ± 2.673.95 ± 2.72
Total score17.95 ± 9.7317.53 ± 9.98
Overall Opinion3.68 ± 2.163.26 ± 2.02
PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
3 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M
score on a scaleFTMB ScarSOC Scar
Pain1.30 ± 0.81.30 ± 0.66
Itchiness2.40 ± 2.112.15 ± 1.69
Color4.55 ± 2.784.60 ± 2.85
Stiffness3.8 ± 2.973.75 ± 2.84
Thickness3.20 ± 2.383.35 ± 2.66
Irregularities3.5 ± 2.43.45 ± 2.5
Total Score18.75 ± 10.1518.55 ± 9.94
Overall Opinion4.15 ± 2.464.15 ± 2.43
PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
3 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M
score on a scaleFTMB ScarSOC Scar
Vascularity1.45 ± 0.761.70 ± 0.73
Pigmentation1.75 ± 0.972.20 ± 1.20
Thickness1.55 ± 11.90 ± 0.97
Relief1.40 ± 0.941.60 ± 0.99
Pliability1.30 ± 0.921.50 ± 0.95
Surface Area1.30 ± 0.731.75 ± 0.85
PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
12 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M
score on a scaleFTMB ScarSOC Scar
Vascularity1.26 ± 0.451.30 ± 0.56
Pigmentation1.74 ± 0.812.04 ± 0.88
Thickness1.70 ± 0.881.96 ± 0.77
Relief1.30 ± 0.561.57 ± 0.79
Pliability1.35 ± 0.571.57 ± 0.73
Surface Area1.35 ± 0.571.78 ± 0.85
PrimaryPatient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M

Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

Time frame:
6 Months
Reported as:
Mean · score on a scale
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M
score on a scaleFTMB ScarSOC Scar
Vascularity1.47 ± 0.771.53 ± 0.77
Pigmentation1.68 ± 0.822.37 ± 0.96
Thickness1.32 ± 0.481.63 ± 0.68
Relief1.16 ± 0.691.32 ± 0.58
Pliability1.16 ± 0.691.11 ± 0.46
Surface Area1.16 ± 0.371.26 ± 0.56
SecondaryScar Area Assessment

eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints.

Time frame:
Week 2, Week 4, Week 6 and Week 8
Reported as:
Mean · cm^2
Scar Area Assessment
cm^2FMTBSuture
Overall1.53 ± 0.102.16 ± 0.11
Week 21.61 ± 0.142.28 ± 0.20
Week 41.69 ± 0.132.65 ± 0.17
Week 61.57 ± 0.101.93 ± 0.25
Week 81.25 ± 0.172.63 ± 0.20
SecondaryGene Regulation- Elastin

Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Gene Regulation- Elastin
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Gene Regulation- Elastin1.09 ± 0.160.80 ± 0.091.04 ± 0.070.82 ± 0.081.21 ± 0.330.92 ± 0.141.01 ± 0.071.17 ± 0.091.21 ± 0.111.22 ± 0.22
SecondaryGene Analysis- Macrophage

Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Gene Analysis- Macrophage
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Gene Analysis- Macrophage1.00 ± 0.180.77 ± 0.040.99 ± 0.100.98 ± 0.220.50 ± 0.051.000 ± 0.170.69 ± 0.141.07 ± 0.140.82 ± 0.300.56 ± 0.04
SecondaryHistology Collagen 3

Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Histology Collagen 3
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Histology Collagen 31.11 ± 0.211.19 ± 0.221.13 ± 0.221.37 ± 1.461.46 ± 0.110.89 ± 0.140.89 ± 0.181.38 ± 0.221.13 ± 0.311.51 ± 0.19
SecondaryChange in Mechanical Properties of Human Tissue

BTC2000 is used to assess changes in skin laxity and elasticity in skin that was treated with each closure. Skin maximum pressure, laxity, elastic/viscoelastic/ultimate deformation, and elasticity is measured to track changes through multiple timepoints.

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · mm
Change in Mechanical Properties of Human Tissue
mmFTMB- BaselineFTMB- 3MFTMB- 6MFTMB- 12MSOC- BaselineSOC- 3MSOC- 6MSOC- 12M
Maximum Pressure (mm)149.70 ± 0.56149.70 ± 0.47149.58 ± 0.51149.62 ± 0.50149.78 ± 0.42149.70 ± 0.47149.58 ± 0.51149.62 ± 0.50
Laxity (mm)1.14 ± 0.600.98 ± 0.431.26 ± 0.461.53 ± 0.591.13 ± 0.601.04 ± 0.41.28 ± 0.391.53 ± 0.59
Elastic Deformation (mm)1.58 ± 0.631.56 ± 0.411.82 ± 0.412.02 ± 0.581.62 ± 0.651.66 ± 0.491.86 ± 0.382.07 ± 0.54
Viscoelastin Deformation (mm).06 ± .02.08 ± .03.08 ± .02.09 ± .03.07 ± .02.08 ± .03.08 ± .02.08 ± .02
Ultimate Deformation (mm)1.64 ± 0.631.64 ± 0.411.91 ± 0.412.11 ± 0.581.68 ± 0.671.74 ± 0.501.94 ± 0.382.15 ± 0.54
Elasticity (mm)0.97 ± 0.480.85 ± 0.261.07 ± 0.341.17 ± 0.531.00 ± 0.520.89 ± 0.381.03 ± 0.311.22 ± 0.43
SecondaryHistology Collagen 1

Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Histology Collagen 1
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Histology Collagen 11.00 ± 0.251.02 ± 0.130.92 ± 0.161.17 ± 0.200.92 ± 0.151.00 ± 0.160.91 ± 0.120.97 ± 0.171.18 ± 0.251.04 ± 0.07
SecondaryScar Maximum Depth

eKare will be used to asses scar area

Time frame:
Week 2, Week 4, Week 6 and Week 8
Reported as:
Mean · mm
Scar Maximum Depth
mmFMTBSuture
Overall0.07 ± 0.010.09 ± 0.00
Week 20.09 ± 0.010.10 ± 0.00
Week 40.07 ± 0.020.09 ± 0.01
Week 60.08 ± 0.010.1 ± 0.01
Week 80.04 ± 0.020.09 ± 0.02
SecondaryInterleukin-8 (IL8)

IL8 is a small protein called a chemokine that play a crucial role in the body's immune and inflammatory responses. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Interleukin-8 (IL8)
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Interleukin-8 (IL8)1.39 ± 0.5130.49 ± 11.9714.75 ± 8.299.38 ± 3.260.18 ± 0.041.09 ± 0.3010.50 ± 0.580.41 ± 0.2113.24 ± 10.641.13 ± 0.42
SecondaryInterleukin-6 (IL6)

IL6 is an inflammatory cytokineses that measures acute phase response following treatment. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline

Time frame:
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Reported as:
Mean · fold change
Interleukin-6 (IL6)
fold changeFMTB- BaselineFMTB- Week 4FMTB- Week 8FMTB- Month 3FMTB- Month 12Suture- BaselineSutures- Week 4Suture- Week 8Suture Month 3Suture- Month 12
Interleukin-6 (IL6)1.25 ± 1.192.89 ± 1.402.23 ± 1.697.96 ± 2.960.53 ± 0.155.89 ± 3.992.07 ± 0.062.83 ± 0.855.24 ± 1.341.75 ± 1.10
SecondaryMeasure of the Skins Function

TEWL is a skin measurement to objectively measure the skins barrier function. The device measures the rate at which water evaporates from the skins surface

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · g/m^2/h
Measure of the Skins Function
g/m^2/hForced Modulated Tissue BridgesStandard of Care
Baseline10.01 ± 4.7710.45 ± 6.84
3 Months10.53 ± 3.969.64 ± 2.92
6 Months9.97 ± 2.899.78 ± 2.88
12 Months9.03 ± 3.539.56 ± 3.41
SecondaryChange in Tissue Density

Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · g/cm^3
Change in Tissue Density
g/cm^3Forced Modulated Tissue Bridges- EpidermisForced Modulated Tissue Bridges- DermisStandard of Care- EpidermisStandard of Care- Dermis
Baseline81.53 ± 20.6455.08 ± 18.4082.67 ± 22.2853.53 ± 21.36
3 Months83.37 ± 16.3828.92 ± 10.5983.37 ± 16.3831.87 ± 13.17
6 Months84.33 ± 21.1523.55 ± 15.4384.33 ± 21.1575.02 ± 9.40
12 Months78.27 ± 13.6818.70 ± 8.8223.50 ± 14.3820.02 ± 9.86
SecondaryChange in Tissue Thickness

Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · um
Change in Tissue Thickness
umForced Modulated Tissue Bridges- EpidermisForced Modulated Tissue Bridges- DermisStandard of Care- EpidermisStandard of Care- Dermis
Baseline102.43 ± 18.701020.87 ± 237.74102.91 ± 197.33977.61 ± 180.79
3 Months92.42 ± 13.311073.79 ± 223.7592.42 ± 13.311073.79 ± 223.75
6 Months96.74 ± 19.091118.37 ± 305.1996.74 ± 19.091118.37 ± 305.19
12 Months98.90 ± 15.231081.14 ± 321.27150.70 ± 197.331915.65 ± 3568.82
SecondaryChange in Tissue Stiffness

Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · mmHg/mm
Change in Tissue Stiffness
mmHg/mmForced Modulated Tissue BridgesStandard of Care
Baseline232.89 ± 70.2916991.96 ± 80448.37
3 Months179.50 ± 40.27185.53 ± 80.62
6 Months173.03 ± 19.12166.90 ± 30.79
12 Months170.31 ± 31.14170.23 ± 30.98
SecondaryChange in Tissue Energy Absorption

Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.

Time frame:
Baseline, 3 Months, 6 Months, and 12 Months
Reported as:
Mean · mmHg*mm
Change in Tissue Energy Absorption
mmHg*mmForced Modulated Tissue BridgesStandard of Care
Baseline66.80 ± 19.4269.77 ± 22.87
3 Months77.17 ± 15.4081.04 ± 21.15
6 Months81.28 ± 10.1984.57 ± 13.99
12 Months85.05 ± 15.0885.32 ± 13.80

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FMTB0/36 (0%)0/36 (0%)1/36 (2.8%)
Suture0/36 (0%)0/36 (0%)1/36 (2.8%)
Most frequent other events
Most frequent other events
EventFMTBSuture
Contact DermititisSkin and subcutaneous tissue disorders1/361/36
Oral ThrushSkin and subcutaneous tissue disorders1/361/36
CellulitisSkin and subcutaneous tissue disorders1/361/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Study Subjects
<=18 years0
Between 18 and 65 years36
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Study Subjects
Female36
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Study Subjects
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American20
White16
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • UT Southwestern Medical Center- Outpatient Building
    Dallas, Texas 75390, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 18, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05028816
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Jeffrey M. Kenkel (Professor of Medicine, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Aug 31, 2021
Start date
Oct 5, 2021
Primary completion
Apr 4, 2024
Completion
Dec 1, 2024
Results posted
Jul 2, 2025
Last update
Jul 2, 2025

Study contacts

Jeffrey Kenkel, MD
principal investigator · Chairman, UT Southwestern

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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